Neuronavigated Transcranial Magnetic Stimulation As An Adjunctive Treatment For Chronic Tinnitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Tinnitus Handicap Inventory (THI)
Study Overview
Brief Summary
This study is testing whether a special type of brain stimulation called neuronavigated TMS can help reduce tinnitus (ringing in the ears). 50 people with tinnitus will each receive 20 treatment sessions - 10 real treatments and 10 sham treatments in random order, with a 2-week break between them. Before starting, participants get an MRI brain scan to guide where the stimulation device is placed. Questionnaires of measuring tinnitus severity will be asked four times throughout the study to determine to check the effect of TMS on treating tinnitus.
Detailed Description
This study aims to investigate the beneficial effects of neuronavigated TMS (nTMS) in alleviating tinnitus symptoms and to establish safety and tolerability of nTMS in patients with tinnitus.
50 eligible subjects will be recruited and be randomized to receive 10 sessions of daily verum nTMS followed by 10 sessions of daily sham nTMS (verum-sham), or sham nTMS followed by verum nTMS (sham-verum). There will be a 2-week break between the two types of nTMS.
MRI will be conducted before the 1st session of nTMS for the TMS navigation system.
Outcome measures include Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI), and Tinnitus-Visual Analogue Scale (T-VAS). All assessment will be evaluated 4 times- before the 1st nTMS session, after the 10th nTMS session, before the 11th nTMS and after the 20th nTMS session.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Assessor and participant will be blinded to the sequence of nTMS assigned to the subject.
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 21-80 years old;
- •Subjective tinnitus severity as per Tinnitus-Visual Analogue Scale of 1/10 and above (in any domain: sound, distress, Quality of Life)
Exclusion Criteria
- •Any metal implants inside the body that are contraindications of MRI scan;
- •Cardiac pacemakers;
- •Epilepsy with recurrent seizures;
- •Cognitively impaired patients will be excluded;
- •Claustrophobia;
- •Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
- •Major depression and a history of psychotic disorders;
- •Terminal diagnosis with life expectancy <=1 year.
Arms & Interventions
real-sham
Subjects will receive 10 sessions of real nTMS, 5 times a week for 2 weeks, followed by 10 sessions of sham nTMS, 5 times a week for 2 weeks. There will be a 2-week break between the 2 types of nTMS.
Intervention: navigated rTMS (Device)
sham-real
Subjects will receive 10 sessions of sham nTMS, 5 times a week for 2 weeks, followed by 10 sessions of real nTMS, 5 times a week for 2 weeks. There will be a 2-week break between the 2 types of nTMS.
Intervention: navigated rTMS (Device)
Outcomes
Primary Outcomes
Tinnitus Handicap Inventory (THI)
Time Frame: Week 0
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Tinnitus Handicap Inventory (THI)
Time Frame: Week 3
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Tinnitus Handicap Inventory (THI)
Time Frame: Week 6
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Tinnitus Handicap Inventory (THI)
Time Frame: Week 7
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Secondary Outcomes
- Tinnitus Functional Index (TFI)(Week 0)
- Tinnitus Functional Index (TFI)(Week 3)
- Tinnitus Functional Index (TFI)(Week 6)
- Tinnitus Functional Index (TFI)(Week 7)
- Tinnitus-Visual Analogue Scale (T-VAS)(Week 0)
- Tinnitus-Visual Analogue Scale (T-VAS)(Week 3)
- Tinnitus-Visual Analogue Scale (T-VAS)(Week 6)
- Tinnitus-Visual Analogue Scale (T-VAS)(Week 7)